57664-170 : Apap 325 mg / Hydrocodone Bitartrate 7.5 mg Oral Tablet

NDC:	57664-170
Labeler:	Caraco Pharmaceutical Laboratories, Ltd.
Product Type:	Human Prescription Drug
Drug Name:	Hydrocodone Bitartrate and Acetaminophen
Dosage Form:	Oral Tablet
Application #:	ANDA090118
Rev. Date:	Mar 30, 2009
CSA Schedule:	CII (US) [1]

^[1] Schedule II / IIN Controlled Substance: High potential for abuse which may lead to severe psychological or physical dependence. (i.e. Narcotics such as Dilaudid, Methadone, Demerol, Oxycodone, Percocet, Fentanyl, Morphine, Opium, Codeine, and Hydrocodone ... Schedule IIN stimulants include non-narcotic Amphetamines such as Dexedrine, Adderall, Desoxyn, Methylphenidate (Ritalin) ... Other Schedule II substances include Amobarbital, Glutethimide, and Pentobarbital. More Details: US Dept of Justice Controlled Substance Schedules.

Appearance:

Markings:	170
Shapes:	Oval
Colors:	Yellow
Size (mm):	13
Segments: *	2
* Segments = the number of equally sized pieces which the pill can be broken into. In this case, a value of 2 indicates a scored pill which can be broken into 2 equal pieces.

NDC Package Codes:

• 57664-170-08: 100 TABLET IN 1 BOTTLE (57664‑170‑08)
• 57664-170-13: 500 TABLET IN 1 BOTTLE (57664‑170‑13)
• 57664-170-18: 1000 TABLET IN 1 BOTTLE (57664‑170‑18)
• 57664-170-83: 30 TABLET IN 1 BOTTLE (57664‑170‑83)
• 57664-170-88: 100 TABLET IN 1 BOTTLE (57664‑170‑88)

Active Ingredients:

• Acetaminophen
• Hydrocodone Bitartrate

Inactive Ingredients:

• Croscarmellose Sodium
• Crospovidone
• Magnesium Stearate
• Cellulose, Microcrystalline
• Povidone
• Starch, Corn
• Stearic Acid
• D&c Yellow No. 10

Pharmaceutical Classes:

• Opioid Agonist [EPC]
• Opioid Agonists [MoA]

Related Products:

Based on records with the same trade name.

• 57664-111 Apap 660 mg / Hydrocodone Bitartrate 10 mg Oral Tablet by Caraco Pharmaceutical Laboratories, Ltd.
• 57664-126 Apap 325 mg / Hydrocodone Bitartrate 5 mg Oral Tablet by Caraco Pharmaceutical Laboratories, Ltd.
• 57664-129 Apap 750 mg / Hydrocodone Bitartrate 7.5 mg Oral Tablet by Caraco Pharmaceutical Laboratories, Ltd.
• 57664-169 Apap 500 mg / Hydrocodone Bitartrate 5 mg Oral Tablet by Caraco Pharmaceutical Laboratories, Ltd.
• 57664-171 Apap 500 mg / Hydrocodone Bitartrate 7.5 mg Oral Tablet by Caraco Pharmaceutical Laboratories, Ltd.
• 57664-173 Apap 650 mg / Hydrocodone Bitartrate 7.5 mg Oral Tablet by Caraco Pharmaceutical Laboratories, Ltd.
• 57664-176 Apap 325 mg / Hydrocodone Bitartrate 10 mg Oral Tablet by Caraco Pharmaceutical Laboratories, Ltd.
• 57664-177 Apap 500 mg / Hydrocodone Bitartrate 10 mg Oral Tablet by Caraco Pharmaceutical Laboratories, Ltd.
• 57664-178 Apap 650 mg / Hydrocodone Bitartrate 10 mg Oral Tablet by Caraco Pharmaceutical Laboratories, Ltd.
• 0121-0655 Hydrocodone Bitartrate and Acetaminophen Oral Solution by Pharmaceutical Associates, Inc.
• 0121-0772 Hydrocodone Bitartrate and Acetaminophen Oral Solution by Pharmaceutical Associates, Inc.
• 0121-1544 Hydrocodone Bitartrate and Acetaminophen Oral Solution by Pharmaceutical Associates, Inc.
• 0121-2316 Hydrocodone Bitartrate and Acetaminophen Oral Solution by Pharmaceutical Associates, Inc.
• 0121-4655 Hydrocodone Bitartrate and Acetaminophen Oral Solution by Pharmaceutical Associates, Inc.
• 0121-4771 Hydrocodone Bitartrate and Acetaminophen Oral Solution by Pharmaceutical Associates, Inc.
• 0121-4772 Hydrocodone Bitartrate and Acetaminophen Oral Solution by Pharmaceutical Associates, Inc.
• 0179-0112 Apap 325 mg / Hydrocodone Bitartrate 5 mg Oral Tablet by Kaiser Foundation Hospitals
• 0179-0113 Apap 325 mg / Hydrocodone Bitartrate 5 mg Oral Tablet by Kaiser Foundation Hospitals
• 0179-0116 Apap 325 mg / Hydrocodone Bitartrate 10 mg Oral Tablet by Kaiser Foundation Hospitals
• 0179-1026 Apap 500 mg / Hydrocodone Bitartrate 5 mg Oral Tablet by Kaiser Foundation Hospitals
• More related products ...

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